Clinical Trial: Dysport® Pediatric Lower Limb Spasticity Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children

Brief Summary: The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb [ Time Frame: Change from baseline to Week 4 ]

The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).


Original Primary Outcome: Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ]

Current Secondary Outcome:

  • Physician's Global Assessment (PGA) of the Treatment Response. [ Time Frame: Week 4 ]
    PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: "how would you rate the response to treatment in the subject's lower limb(s) since the last injection?" Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).
  • Goal Attainment Scale (GAS) Score [ Time Frame: Week 4 ]
    GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).


Original Secondary Outcome:

  • Physician's Global Assessment (PGA) of the Treatment Response. [ Time Frame: Week 4 ]
  • Measurement of progress towards individual therapy [ Time Frame: Week 4 ]


Information By: Ipsen

Dates:
Date Received: November 25, 2010
Date Started: July 2011
Date Completion:
Last Updated: December 8, 2016
Last Verified: December 2016